Tag Archives: medical device tax

House GOP Moving Ahead on Controversial ACA Repeal & Replace Bill; First of Three Planned Phases of Health Reform

The House of Representatives is moving ahead on the Republican plan -– the American Health Care Act (AHCA) – that would repeal and replace major provisions of the Affordable Care Act (ACA). On March 16, 2017, the House Budget Committee approved sending the bill to the full House as part of fiscal year 2017 budget … Continue Reading

Looking Ahead to a Trump Administration: Health Care and Life Sciences Industry Perspectives

Observers are digesting what the Trump Administration will mean for the health care and life sciences industry.  Forecasting is more challenging for this incoming Administration than most given the relatively sparse policy details released during the campaign and the lack of a government service record to examine for clues.  Today President-elect Trump’s transition team released … Continue Reading

Congressional Leaders Announce Spending/Tax Deal with Medicare and ACA Provisions; House Approves Tax Package

On December 15, 2015, Congressional leaders released sweeping spending and tax proposals, including a number of provisions impacting Medicare and the Affordable Care Act (ACA). The legislation is being considered on a fast track; the House approved the tax component of the package today, and it is scheduled to vote on the appropriations bill tomorrow, with … Continue Reading

House Passes Budget Reconciliation Bill with ACA Mandate, Tax Repeal Provisions

Today the House of Representatives approved H.R. 3762, budget “reconciliation” legislation that would repeal four provisions of the Affordable Care Act (ACA).  Specifically, the legislation would repeal the ACA employer and individual insurance mandates, the medical device excise tax, and the so-called “Cadillac tax” on high-cost health plans (an earlier House Ways and Means Committee provision that would … Continue Reading

House Ways and Means Committee Approves Bills to Repeal ACA Taxes, Mandates, IPAB

On September 29, 2015, the House Ways and Means Committee approved budget “reconciliation” legislation that calls for repeal of five provisions of the Affordable Care Act (ACA). Specifically, the legislation would repeal the employer and individual insurance mandates, the medical device excise tax, the so-called “Cadillac tax on high-cost health plans, and the Independent Payment … Continue Reading

House Passes Bills to Repeal ACA Medical Device Tax and IPAB, Revise Medicare Advantage Policy

The House of Representatives has taken action on a number of bills to modify certain Affordable Care Act (ACA) provisions, revise Medicare Advantage policies, and make other health policy changes. On June 23, 2015, the House voted to approve H.R. 1190, a bill to repeal the Independent Payment Advisory Board (IPAB), by a vote of 244 to … Continue Reading

Ways and Means Committee Approves Health Policy Bills, Including Repeal of ACA Medical Device Tax & IPAB, and Medicare Advantage/LTCH Policy Changes

On June 2, 2015, the House Ways and Means Committee approved ten health policy bills, including legislation to repeal the ACA’s medical device tax and the Independent Payment Advisory Board (IPAB). Other measures would make a series of changes to Medicare Advantage (MA) requirements and Medicare long-term care hospital (LTCH) policy. Specifically, the Committee approved the … Continue Reading

Congressional Health Policy Hearings

Congressional committees have held a number of hearings recently on health policy issues, include the following A House Energy and Commerce Health Subcommittee hearing on “Medicare Post-Acute Care Delivery and Options to Improve It.”  A Senate Commerce Committee hearing on “Advancing Telehealth Through Connectivity.” A Senate Finance Committee hearing on the impact of the ACA … Continue Reading

Device Manufacturer Files Challenge to OIG Special Fraud Alert on Physician-Owned Distributors

As reported on our sister blog, http://www.lifescienceslegalupdate.com/, Reliance Medical Systems, LLC, filed a complaint in the U.S. District Court for the Central District of California this week that seeks a declaration that an Office of Inspector General (OIG) Special Fraud Alert on physician-owned distributors (PODs) unfairly and unconstitutionally burdens First Amendment rights of free speech … Continue Reading

IRS Issues Regulations to Implement ACA Medical Device Tax

This post was also written by Ruth N. Holzman and Angelo Ciavarella. On December 7, 2012, the IRS published final regulations that provide guidance on the 2.3% excise tax imposed on any sale occurring after December 31, 2012, of any “taxable medical device” by the manufacturer, producer or importer of such device (such tax enacted as part … Continue Reading

House Approves ACA Device Tax Repeal Bill in Face of Veto Threat

This post was also written by Ruth N. Holzman and Angelo Ciavarella. Yesterday the House approved by a vote of 270-146 legislation to repeal the ACA’s controversial 2.3% excise tax on the sale price of certain medical devices, which is scheduled to apply to sales after December 31, 2012. The repeal provision is included in H.R. 436, the … Continue Reading

IRS Proposes Regulations to Implement ACA Medical Device Tax

This post was also written by Ruth N. Holzman, Angelo Ciavarella and Jennifer A. Goldstein. On February 7, 2012, the Internal Revenue Service (IRS) published proposed regulations to implement the Affordable Care Act’s (ACA) 2.3% excise tax on the sale price of medical devices sold by the manufacturer, producer, or importer of the device after … Continue Reading

IRS Guidance on ACA Fee on Prescription Drug Manufacturers/Importers; Comment Request on Medical Device Excise Tax.

The Internal Revenue Service (IRS) has issued documents related to the annual fee for manufacturers and importers of brand name pharmaceuticals under section 9008 of the ACA, which is payable beginning in 2011. Specifically, IRS Notice 2010-71 describes a proposed methodology for calculating the fee (including a discussion of covered entities, sales taken into account; … Continue Reading

Reed Smith Health Care Reform Review: The Affordable Care Act – Analysis and Implications for Drug, Device and Biotech Manufacturers

In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). Together, these sweeping measures expand access to health insurance (including subsidies, mandates, and market reforms); reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms. In this analysis, we concentrate on those provisions in the new law that will affect life sciences entities: pharmaceutical, device, and biologics manufacturers. These include significant revisions to the Medicaid drug rebate program and the Medicare Part D prescription drug program; an expansion of the Public Health Service Section 340B drug discount program; the imposition of substantial new industry fees and excise taxes; creation of an abbreviated approval pathway for follow-on biologics; and sweeping new reporting and disclosure requirements affecting all manufacturers regarding their relationships with physicians and teaching hospitals, among other changes. Many of the new provisions require the Secretary of the Department of Health and Human Services (HHS) to issue implementing regulations. We have referenced notices that have been published already, and we will be reporting on additional developments in the coming months.… Continue Reading
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